C&E Europe wins on quality, not just costs

Running clinical trials in Russia, Ukraine and Eastern Europe is not only cheaper than in the West but can generate better quality data, according to the head of a US-based contract research organisation (CRO) that operates in the region.

Speaking at last week’s Clinical Outsourcing World Europe 2009 conference in London, David Passov, president and chief operating officer of ClinStar, noted that so far the US Food and Drug Administration had audited a total of 35 clinical trial sites in Russia and four in Ukraine.

Putting these together showed that 54% of the FDA inspections returned a verdict of ‘No Action Indicated’, compared with 38% for sites in North America and Western Europe. The FDA audits resulted in ‘Voluntary Action Indicated’ for 44% of the sites in Russia and Ukraine versus 55% of the North American and Western European sites. The respective figures for ‘Official Action Indicated’ were 2% and 7%.

Passov also quoted Dr Antoine El-Hage, branch chief, Good Clinical Practice II, in the FDA Office of Investigations, as saying: “Compared to other non-USA sites, Russia is better”.

One of the reasons why sites in Russia and Ukraine had an edge on quality over their western counterparts was that almost all of the clinical research associates (CRAs) working in the sector either were medical doctors or had degrees in the biological sciences, Passov suggested. That meant they had peer-to-peer relationships with study investigators. The CRAs also spent a lot more time with investigators, partly for training purposes, he noted.

As for the financial advantages, CRO fees used to be much lower in Russia and Ukraine than in the West; now they were only “somewhat lower”, Passov told the conference, adding that the same went for investigator fees. On the other hand, CROs in these countries did not keep timesheets, so they often devoted more hours and attention to a study than was stipulated in the contract.

The real cost savings, though, came from patient recruitment, which was up to 25 times faster in Russia and Ukraine than in the West. Slow recruitment was the most frequently cited cause of delays in clinical trials and the average operational cost per trial could run from US$160,833 to US$1,083,333 a month, Passov pointed out.

Among the factors that made recruitment so much easier in countries like Russia and Ukraine were huge patient populations (including drug-naïve patients); the incentive for patients to access new medicines, better care and more sophisticated diagnostics; a vertical and centralised healthcare system; highly qualified doctors motivated by financial remuneration and the chance to visit conferences and work with western colleagues; and far less competition for qualified investigators.

The cost savings from quicker patient recruitment were “several orders of magnitude” more than those available from lower CRO or investigator fees, Passov said.